Company profile for Moderna Therapeutics

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About

Moderna is a leader in the discovery and development of messenger RNA (mRNA) therapeutics and vaccines, an entirely new class of medicines that directs the body’s cells to produce intracellular or secreted proteins that can have a therapeutic or preventive benefit for both patients and healthy individuals. With its breakthrough platform, Moderna is creating mRNA medicines for a wide range of diseases and conditions, in many ...
Moderna is a leader in the discovery and development of messenger RNA (mRNA) therapeutics and vaccines, an entirely new class of medicines that directs the body’s cells to produce intracellular or secreted proteins that can have a therapeutic or preventive benefit for both patients and healthy individuals. With its breakthrough platform, Moderna is creating mRNA medicines for a wide range of diseases and conditions, in many cases by addressing currently undruggable targets or underserved areas of medical need. Moderna is developing its innovative mRNA medicines for infectious diseases.

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CONTACT DETAILS

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Country
Country
U.S.A
Address
Address
200 Technology Sq, Cambridge, Massachusetts 02139, US
Telephone
Telephone
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YouTube
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Twitter

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Events

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NEWS #PharmaBuzz

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https://firstwordpharma.com/story/7209742

FIRSTWORD PHARMA
26 Apr 2026

https://www.reuters.com/business/healthcare-pharmaceuticals/moderna-wins-eu-approval-combined-flu-covid-shot-older-adults-2026-04-21/

REUTERS
22 Apr 2026

https://www.pharmiweb.com/press-release/2026-04-21/moderna-announces-data-to-be-presented-at-2026-asco-annual-meeting

PHARMIWEB
21 Apr 2026

https://www.news.sanofi.us/2026-04-18-ESCMID-Sanofis-NUVAXOVID-TM-COVID-19-vaccine-showed-better-tolerability-than-mNEXSPIKE-in-head-to-head-study

PRESS RELEASE
20 Apr 2026

https://www.pharmiweb.com/press-release/2026-04-15/moderna-to-report-first-quarter-2026-financial-results-on-friday-may-1-2026

PHARMIWEB
15 Apr 2026

https://www.pharmiweb.com/press-release/2026-04-06/moderna-to-present-revaccination-data-for-its-investigational-seasonal-influenza-vaccine-and-for-mre

PHARMIWEB
06 Apr 2026

Drugs in Development

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Details:

MRNA-4157 (Intismeran) is a vaccine drug, which is currently being evaluated in Phase III clinical studies for the treatment of carcinoma, non-small-cell lung.


Lead Product(s): Intismeran,V940,mRNA-4157,MK-3475A,Pembrolizumab

Therapeutic Area: Oncology Brand Name: mRNA-4157

Study Phase: Phase IIIProduct Type: Vaccine

Recipient: Merck & Co

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable April 07, 2026

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Bioprocess International Europe
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Bioprocess International Europe
Not Confirmed

Details : MRNA-4157 (Intismeran) is a vaccine drug, which is currently being evaluated in Phase III clinical studies for the treatment of carcinoma, non-small-cell lung.

Product Name : mRNA-4157

Product Type : Vaccine

Upfront Cash : Inapplicable

April 07, 2026

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Details:

MRNA-1018-H5 is a Vaccine drug candidate, which is currently being evaluated in Phase III clinical studies for the treatment of Influenza, Human.


Lead Product(s): mRNA-1018-H5

Therapeutic Area: Infections and Infectious Diseases Brand Name: Undisclosed

Study Phase: Phase IIIProduct Type: Vaccine

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable March 27, 2026

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Bioprocess International Europe
Not Confirmed
Bioprocess International Europe
Not Confirmed

Details : MRNA-1018-H5 is a Vaccine drug candidate, which is currently being evaluated in Phase III clinical studies for the treatment of Influenza, Human.

Product Name : Undisclosed

Product Type : Vaccine

Upfront Cash : Inapplicable

March 27, 2026

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Details:

mRNA-1189 is a vaccine drug, which is currently being evaluated in Phase I clinical studies for the treatment of epstein-barr virus infections.


Lead Product(s): mRNA-1189

Therapeutic Area: Infections and Infectious Diseases Brand Name: Undisclosed

Study Phase: Phase IProduct Type: Vaccine

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable March 18, 2026

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Bioprocess International Europe
Not Confirmed
Bioprocess International Europe
Not Confirmed

Details : mRNA-1189 is a vaccine drug, which is currently being evaluated in Phase I clinical studies for the treatment of epstein-barr virus infections.

Product Name : Undisclosed

Product Type : Vaccine

Upfront Cash : Inapplicable

March 18, 2026

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Details:

The collaboration aims to advance propionic acidemia research with mRNA-3927, an oligonucleotide targeting PCCA mRNA.


Lead Product(s): mRNA-3927

Therapeutic Area: Neurology Brand Name: Undisclosed

Study Phase: Phase I/ Phase IIProduct Type: Oligonucleotide

Sponsor: Recordati

Deal Size: $160.0 million Upfront Cash: $50.0 million

Deal Type: Collaboration January 29, 2026

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Bioprocess International Europe
Not Confirmed
Bioprocess International Europe
Not Confirmed

Details : The collaboration aims to advance propionic acidemia research with mRNA-3927, an oligonucleotide targeting PCCA mRNA.

Product Name : Undisclosed

Product Type : Oligonucleotide

Upfront Cash : $50.0 million

January 29, 2026

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Details:

The funding will support the development of mRNA-1018, a vaccine targeting Hemagglutinin, to address the Bird Flu.


Lead Product(s): mRNA-1018

Therapeutic Area: Infections and Infectious Diseases Brand Name: Undisclosed

Study Phase: Phase I/ Phase IIProduct Type: Vaccine

Sponsor: Global Coalition

Deal Size: $54.3 million Upfront Cash: Undisclosed

Deal Type: Funding December 18, 2025

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Bioprocess International Europe
Not Confirmed
Bioprocess International Europe
Not Confirmed

Details : The funding will support the development of mRNA-1018, a vaccine targeting Hemagglutinin, to address the Bird Flu.

Product Name : Undisclosed

Product Type : Vaccine

Upfront Cash : Undisclosed

December 18, 2025

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Details:

MRNA-1273 (mRNA-1273) is a Vaccine drug candidate, which is currently being evaluated in Phase IV clinical studies for the treatment of COVID-19.


Lead Product(s): Elasomeran

Therapeutic Area: Infections and Infectious Diseases Brand Name: mRNA-1273

Study Phase: Phase IVProduct Type: Vaccine

Sponsor: Tor Biering-Sørensen

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable December 12, 2025

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Bioprocess International Europe
Not Confirmed
Bioprocess International Europe
Not Confirmed

Details : MRNA-1273 (mRNA-1273) is a Vaccine drug candidate, which is currently being evaluated in Phase IV clinical studies for the treatment of COVID-19.

Product Name : mRNA-1273

Product Type : Vaccine

Upfront Cash : Inapplicable

December 12, 2025

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Details:

MRNA-1273 (Elasomeran) is a Vaccine drug candidate, which is currently being evaluated in Phase IV clinical studies for the treatment of COVID-19.


Lead Product(s): Elasomeran,mRNA-1283

Therapeutic Area: Infections and Infectious Diseases Brand Name: mRNA-1273

Study Phase: Phase IVProduct Type: Vaccine

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable December 05, 2025

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Bioprocess International Europe
Not Confirmed
Bioprocess International Europe
Not Confirmed

Details : MRNA-1273 (Elasomeran) is a Vaccine drug candidate, which is currently being evaluated in Phase IV clinical studies for the treatment of COVID-19.

Product Name : mRNA-1273

Product Type : Vaccine

Upfront Cash : Inapplicable

December 05, 2025

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Details:

MRNA-4157 (Intismeran Autogene) is a Vaccine drug candidate, which is currently being evaluated in Phase II clinical studies for the treatment of Carcinoma, Non-Small-Cell Lung.


Lead Product(s): Intismeran Autogene,Pembrolizumab,Carboplatin,Paclitaxel

Therapeutic Area: Oncology Brand Name: mRNA-4157

Study Phase: Phase IIProduct Type: Vaccine

Recipient: Merck & Co

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable October 28, 2025

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Bioprocess International Europe
Not Confirmed
Bioprocess International Europe
Not Confirmed

Details : MRNA-4157 (Intismeran Autogene) is a Vaccine drug candidate, which is currently being evaluated in Phase II clinical studies for the treatment of Carcinoma, Non-Small-Cell Lung.

Product Name : mRNA-4157

Product Type : Vaccine

Upfront Cash : Inapplicable

October 28, 2025

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Details:

Spikevax 2025-2026 formula has been approved for the prevention of COVID-19 in adults 65 years and older or individuals 12 years.


Lead Product(s): Elasomeran,COVID-19 Vaccine, mRNA

Therapeutic Area: Infections and Infectious Diseases Brand Name: Spikevax

Study Phase: Approved FDFProduct Type: Oligonucleotide

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable August 27, 2025

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Bioprocess International Europe
Not Confirmed
Bioprocess International Europe
Not Confirmed

Lead Product(s) : Elasomeran,COVID-19 Vaccine, mRNA

Therapeutic Area : Infections and Infectious Diseases

Highest Development Status : Approved FDF

Partner/Sponsor/Collaborator : Undisclosed

Deal Size : Inapplicable

Deal Type : Inapplicable

Details : Spikevax 2025-2026 formula has been approved for the prevention of COVID-19 in adults 65 years and older or individuals 12 years.

Product Name : Spikevax

Product Type : Oligonucleotide

Upfront Cash : Inapplicable

August 27, 2025

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Details:

MRNA-1345 is a Vaccine drug candidate, which is currently being evaluated in Phase III clinical studies for the treatment of Respiratory Syncytial Virus Infections.


Lead Product(s): mRNA-1345

Therapeutic Area: Infections and Infectious Diseases Brand Name: Undisclosed

Study Phase: Phase IIIProduct Type: Vaccine

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable August 12, 2025

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Bioprocess International Europe
Not Confirmed
Bioprocess International Europe
Not Confirmed

Details : MRNA-1345 is a Vaccine drug candidate, which is currently being evaluated in Phase III clinical studies for the treatment of Respiratory Syncytial Virus Infections.

Product Name : Undisclosed

Product Type : Vaccine

Upfront Cash : Inapplicable

August 12, 2025

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FDF Dossiers

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Brand Name : Spikevax JN (mRNA-)

Stanford Drug Discovery Symposium
Not Confirmed
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Brand Name : Spikevax JN (mRNA-)

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Stanford Drug Discovery Symposium
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Moderna Therapeutics

Dosage Form : Dispersion For Injection

Brand Name : Spikevax JN (mRNA-)

Dosage Strength : 0.10mg/dose

Packaging :

Approval Date : 09/09/2024

Application Number : 69788

Regulatory Info : Allowed

Registration Country : Switzerland

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Brand Name : SPIKEVAX

Stanford Drug Discovery Symposium
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Brand Name : SPIKEVAX

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Stanford Drug Discovery Symposium
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Moderna Therapeutics

Dosage Form : DISPERSION

Brand Name : SPIKEVAX

Dosage Strength : 0.1MG/ML

Packaging :

Approval Date :

Application Number : 2541270

Regulatory Info : SCHEDULE D

Registration Country : Canada

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Brand Name : SPIKEVAX

Stanford Drug Discovery Symposium
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Brand Name : SPIKEVAX

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Moderna Therapeutics

Dosage Form : DISPERSION

Brand Name : SPIKEVAX

Dosage Strength : 50MCG/0.5ML

Packaging :

Approval Date :

Application Number : 2557770

Regulatory Info : SCHEDULE D

Registration Country : Canada

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Brand Name : Nail Wax Jn.1

Stanford Drug Discovery Symposium
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Brand Name : Nail Wax Jn.1

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Stanford Drug Discovery Symposium
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Moderna Therapeutics

Dosage Form : Injectable Solution

Brand Name : Nail Wax Jn.1

Dosage Strength : 0.1mg/ml

Packaging :

Approval Date : 10-09-2024

Application Number : 2.02E+13

Regulatory Info : Approved

Registration Country : Sweden

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Brand Name : Nail Wax Jn.1

Stanford Drug Discovery Symposium
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Brand Name : Nail Wax Jn.1

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Stanford Drug Discovery Symposium
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Moderna Therapeutics

Dosage Form : Injectable Solution

Brand Name : Nail Wax Jn.1

Dosage Strength : 50mcg

Packaging :

Approval Date : 10-09-2024

Application Number : 2.02E+13

Regulatory Info : Approved

Registration Country : Sweden

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Brand Name : Nail Wax Jn.1

Stanford Drug Discovery Symposium
Not Confirmed
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Brand Name : Nail Wax Jn.1

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Stanford Drug Discovery Symposium
Not Confirmed

Moderna Therapeutics

Dosage Form : Solution For Injection

Brand Name : Nail Wax Jn.1

Dosage Strength : 50mcg

Packaging :

Approval Date : 10-09-2024

Application Number : 2.02E+13

Regulatory Info : Approved

Registration Country : Sweden

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Brand Name : Spikevax Xbb.1.5

Stanford Drug Discovery Symposium
Not Confirmed
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Brand Name : Spikevax Xbb.1.5

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Stanford Drug Discovery Symposium
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Moderna Therapeutics

Dosage Form : Injectable Solution

Brand Name : Spikevax Xbb.1.5

Dosage Strength : 0.1mg/ml

Packaging :

Approval Date : 15-09-2023

Application Number : 28107037823

Regulatory Info : Prescription

Registration Country : Denmark

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Brand Name : Spikevax Xbb.1.5

Stanford Drug Discovery Symposium
Not Confirmed
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Brand Name : Spikevax Xbb.1.5

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Stanford Drug Discovery Symposium
Not Confirmed

Moderna Therapeutics

Dosage Form : Injectable Solution

Brand Name : Spikevax Xbb.1.5

Dosage Strength : 50mcg

Packaging :

Approval Date : 15-09-2023

Application Number : 28107038023

Regulatory Info : Prescription

Registration Country : Denmark

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Brand Name : Spikevax Xbb.1.5

Stanford Drug Discovery Symposium
Not Confirmed
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Brand Name : Spikevax Xbb.1.5

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Stanford Drug Discovery Symposium
Not Confirmed

Moderna Therapeutics

Dosage Form : Dispersion For Injection

Brand Name : Spikevax Xbb.1.5

Dosage Strength : 50mcg

Packaging :

Approval Date : 15-09-2023

Application Number : 28107038123

Regulatory Info : Prescription

Registration Country : Denmark

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Brand Name : Nail Wax Xbb.1.5

Stanford Drug Discovery Symposium
Not Confirmed
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Brand Name : Nail Wax Xbb.1.5

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Stanford Drug Discovery Symposium
Not Confirmed

Moderna Therapeutics

Dosage Form : Injectable Solution

Brand Name : Nail Wax Xbb.1.5

Dosage Strength : 0.1mg/ml

Packaging :

Approval Date : 15-09-2023

Application Number : 2.02E+13

Regulatory Info : Approved

Registration Country : Sweden

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Europe

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01

Brand Name : Spikevax JN (mRNA-)

Bioprocess International Europe
Not Confirmed
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Brand Name : Spikevax JN (mRNA-)

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Bioprocess International Europe
Not Confirmed

Moderna Therapeutics

Dosage Form : Dispersion For Injection

Dosage Strength : 0.10mg/dose

Packaging :

Brand Name : Spikevax JN (mRNA-)

Approval Date : 09/09/2024

Application Number : 69788

Regulatory Info : Allowed

Registration Country : Switzerland

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Brand Name : Nail Wax Jn.1

Bioprocess International Europe
Not Confirmed
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Brand Name : Nail Wax Jn.1

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Bioprocess International Europe
Not Confirmed

Moderna Therapeutics

Dosage Form : Injectable Solution

Dosage Strength : 0.1mg/ml

Packaging :

Brand Name : Nail Wax Jn.1

Approval Date : 10-09-2024

Application Number : 2.02E+13

Regulatory Info : Approved

Registration Country : Sweden

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Brand Name : Nail Wax Jn.1

Bioprocess International Europe
Not Confirmed
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Brand Name : Nail Wax Jn.1

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Bioprocess International Europe
Not Confirmed

Moderna Therapeutics

Dosage Form : Injectable Solution

Dosage Strength : 50mcg

Packaging :

Brand Name : Nail Wax Jn.1

Approval Date : 10-09-2024

Application Number : 2.02E+13

Regulatory Info : Approved

Registration Country : Sweden

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Brand Name : Nail Wax Jn.1

Bioprocess International Europe
Not Confirmed
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Brand Name : Nail Wax Jn.1

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Bioprocess International Europe
Not Confirmed

Moderna Therapeutics

Dosage Form : Solution For Injection

Dosage Strength : 50mcg

Packaging :

Brand Name : Nail Wax Jn.1

Approval Date : 10-09-2024

Application Number : 2.02E+13

Regulatory Info : Approved

Registration Country : Sweden

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Brand Name : Spikevax Xbb.1.5

Bioprocess International Europe
Not Confirmed
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Brand Name : Spikevax Xbb.1.5

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Bioprocess International Europe
Not Confirmed

Moderna Therapeutics

Dosage Form : Injectable Solution

Dosage Strength : 0.1mg/ml

Packaging :

Brand Name : Spikevax Xbb.1.5

Approval Date : 15-09-2023

Application Number : 28107037823

Regulatory Info : Prescription

Registration Country : Denmark

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Brand Name : Spikevax Xbb.1.5

Bioprocess International Europe
Not Confirmed
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Brand Name : Spikevax Xbb.1.5

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Bioprocess International Europe
Not Confirmed

Moderna Therapeutics

Dosage Form : Injectable Solution

Dosage Strength : 50mcg

Packaging :

Brand Name : Spikevax Xbb.1.5

Approval Date : 15-09-2023

Application Number : 28107038023

Regulatory Info : Prescription

Registration Country : Denmark

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Brand Name : Spikevax Xbb.1.5

Bioprocess International Europe
Not Confirmed
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Brand Name : Spikevax Xbb.1.5

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Bioprocess International Europe
Not Confirmed

Moderna Therapeutics

Dosage Form : Dispersion For Injection

Dosage Strength : 50mcg

Packaging :

Brand Name : Spikevax Xbb.1.5

Approval Date : 15-09-2023

Application Number : 28107038123

Regulatory Info : Prescription

Registration Country : Denmark

blank

08

Brand Name : Nail Wax Xbb.1.5

Bioprocess International Europe
Not Confirmed
arrow

Brand Name : Nail Wax Xbb.1.5

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Bioprocess International Europe
Not Confirmed

Moderna Therapeutics

Dosage Form : Injectable Solution

Dosage Strength : 0.1mg/ml

Packaging :

Brand Name : Nail Wax Xbb.1.5

Approval Date : 15-09-2023

Application Number : 2.02E+13

Regulatory Info : Approved

Registration Country : Sweden

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09

Brand Name : Nail Wax Xbb.1.5

Bioprocess International Europe
Not Confirmed
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Brand Name : Nail Wax Xbb.1.5

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Bioprocess International Europe
Not Confirmed

Moderna Therapeutics

Dosage Form : Injectable Solution

Dosage Strength : 50mcg

Packaging :

Brand Name : Nail Wax Xbb.1.5

Approval Date : 15-09-2023

Application Number : 2.02E+13

Regulatory Info : Approved

Registration Country : Sweden

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10

Brand Name : Nail Wax Xbb.1.5

Bioprocess International Europe
Not Confirmed
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Brand Name : Nail Wax Xbb.1.5

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Bioprocess International Europe
Not Confirmed

Moderna Therapeutics

Dosage Form : Solution For Injection

Dosage Strength : 50mcg

Packaging :

Brand Name : Nail Wax Xbb.1.5

Approval Date : 15-09-2023

Application Number : 2.02E+13

Regulatory Info : Approved

Registration Country : Sweden

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Excipients

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USDMF

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SM-102 NOVEL LIPID EXCIPIENT

BPI Europe
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SM-102 NOVEL LIPID EXCIPIENT

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BPI Europe
Not Confirmed

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 31352

Submission : 2017-02-27

Status : Inactive

Type : IV

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SM-86 A NOVEL LIPID EXCIPIEN...

BPI Europe
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SM-86 A NOVEL LIPID EXCIPIEN...

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BPI Europe
Not Confirmed

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 31194

Submission : 2016-12-14

Status : Inactive

Type : IV

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Inspections and registrations

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FDA

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FDA Audited

USA
PCC
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FDA Audited

USA
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PCC
Not Confirmed

Moderna Therapeutics

City : Norwood

State : Massachusetts

Country/Area : U.S.A

Zip : 2062

District :

Center :

Project Area : Vaccines and Allergenic Products

District Decision : No Action Indicated

Inspection End Date : 2024-04-19

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FDA Audited

USA
PCC
Not Confirmed
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FDA Audited

USA
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PCC
Not Confirmed

Moderna Therapeutics

City : Norwood

State : Massachusetts

Country/Area : U.S.A

Zip : 2062

District :

Center :

Project Area : Vaccines and Allergenic Products

District Decision : Voluntary Action Indicated

Inspection End Date : 2023-09-21

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